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Merck's heart drug flunks Phase III trial
June 5, 2009 — 9:26am ET
Merck's plans for acute heart failure drug rolofylline (MK-7418) took a hit this morning as the company announced a Phase III trial of the drug missed primary and secondary endpoints. Rolofylline is designed to prevent the kidneys from reabsorbing salt and water, as well as increase blood flow and urine output, according to the Wall Street Journal.
The 2,033-patient study was designed to evaluate whether rolofylline would improve symptoms of acute heart failure compared to placebo. Merck also tested whether a 30 mg dose of the drug would reduce the risk of death or cardiovascular or renal re-hospitalization 60 days after treatment, and if it would reduce the incidence of persistent kidney impairment. Preliminary results indicated rolofylline failed to achieve any of those targets. Rolofylline was acquired by Merck through NovaCardia, which Merck purchased for $350 million in 2007.
"Advances to help patients with acute heart failure, a disease that is the leading cause of hospitalization for patients over age 65 and that is associated with a high rate of mortality, have long been elusive," said Dan Bloomfield, M.D., executive director, cardiovascular research, Merck Research Laboratories. "These results are disappointing because we had been hopeful that blocking the adenosine A1 receptor with rolofylline would prove to be a useful new approach for these patients." Merck will continue to analyze data from the study, but won't submit the drug for FDA approval this year as originally planned.
Ragazzi beccatevi questaaaaaaaaaaa!!!!!!!!!!!!!!!!!!!!!!!!
Merck's heart drug flunks Phase III trial
June 5, 2009 — 9:26am ET
Merck's plans for acute heart failure drug rolofylline (MK-7418) took a hit this morning as the company announced a Phase III trial of the drug missed primary and secondary endpoints. Rolofylline is designed to prevent the kidneys from reabsorbing salt and water, as well as increase blood flow and urine output, according to the Wall Street Journal.
The 2,033-patient study was designed to evaluate whether rolofylline would improve symptoms of acute heart failure compared to placebo. Merck also tested whether a 30 mg dose of the drug would reduce the risk of death or cardiovascular or renal re-hospitalization 60 days after treatment, and if it would reduce the incidence of persistent kidney impairment. Preliminary results indicated rolofylline failed to achieve any of those targets. Rolofylline was acquired by Merck through NovaCardia, which Merck purchased for $350 million in 2007.
"Advances to help patients with acute heart failure, a disease that is the leading cause of hospitalization for patients over age 65 and that is associated with a high rate of mortality, have long been elusive," said Dan Bloomfield, M.D., executive director, cardiovascular research, Merck Research Laboratories. "These results are disappointing because we had been hopeful that blocking the adenosine A1 receptor with rolofylline would prove to be a useful new approach for these patients." Merck will continue to analyze data from the study, but won't submit the drug for FDA approval this year as originally planned.
